Clinical study site network hyperCORE includes more than 90 active research sites around the globe, with member companies that hold than a century of combined experience and 6,000 completed studies under their belts. Venn herself holds more than two decades of experience in the field.
Venn (KV) recently spoke with Outsourcing-Pharma (OSP) about the organization, her career, and the future of the industry.
OSP: Please start off by telling us about hyperCORE—who they are, their history, and what sets them apart from similar organizations.
KV: Formed in 2019, hyperCORE International (hCI) is a multi-therapeutic, super network of highly experienced and awarded clinical research companies. Its unique ownership model combines the strengths of nine leading independent research organizations (IROs) under one umbrella focusing on agility and innovation to accelerate clinical research through centralization of core operations and innovative strategic partnerships with Pharma/CROs.
Its primary goal is to modernize the highly fragmented and inefficient research site model by assembling the industry’s leading site networks under one moniker facilitating exponential efficiencies at an unprecedented scale.
OSP: Clinical research is a fascinating, dynamic field—how did you come to enter the industry?
KV: Quite honestly, I stumbled into this opportunity. I started at LMC Manna over 22 years ago when it was one site and a specialty practice where I was hired as an educator and research was a way to provide funds to healthcare professionals with the mandate to provide better patient care models in the community setting outside of a hospital for chronic disease management.
Research fascinated me because it gave me a fast pace environment to continually learn and grow. Fortunate enough to hold every position at a site it gave me the understanding of how to improve the research practice over the years and build it into a nationally recognized multi-site clinical research network industry leader.
OSP: Over the course of your career, what have been some of the most notable changes and evolutions?
KV: In the early days, the first major change was the transition from paper CRF to electronic case report form. As we implemented a research consent process early on in our physician practices it allowed us to adopt big data processes to leverage our knowledge and expertise in clinical research.
Presently, we have become a recognized leader of big data, real world evidence by use of our knowledge and expertise in coordinating one of the largest global diabetes registries. Our most current evolution is embracing the transition from traditional office visits to include virtual and de-centralized clinical trial models to the full spectrum of offerings in clinical research.
Technology has exploded in the past year due to COVID and this is an aspect we have used for many years to leverage efficiencies and excellence. It excites me the challenge that has been presented and feel confident this movement will be better for all – most importantly the patient experience.
OSP: What do you find most challenging about your work?
KV: As a site, often there are many decisions that are out of our control. The industry is incredibly fragmented and disconnected that it often impedes growth and evolution to what we know the potential opportunities could be if we were more aligned and working together in unison.
Our ultimate goal is to continue to highlight our capabilities and form the trusted relationships so that there is a mutual understanding of what decisions should be made to forge ahead in a meaningful way.
OSP: Similarly, what about life as a clinical research leader do you think is the most rewarding?
KV:100% it’s always been about the patients – how research can provide new therapies, devices and care pathways to improve outcomes for all.
OSP: The pandemic has thrown clinical trials for a loop—how has hyperCORE responded, and helped clients weather the storm?
KV: I am continually impressed by the response from our group – start up timelines under one week, top global enrollers in treatment trials, significant portion of volunteers vaccinated in COVID trials, priority to focus on inclusion of a diverse group of ethnicities and a mission to share best practices. Many leaders within our team have presented and been included on panels to share their insights with the entire research community in hopes to provide insights for all to better meet the demands that are presented to us during this time.
We have always tried to focus on being a true partner – what is it that our clients need and because we are a group of entrepreneurs we welcome the adversity because we know this will inevitably be a time for growth and development that will make us stronger.
OSP: You’d said you feel hyperCORE is uniquely poised to lead the future direction of the clinical research field—could you please share your thoughts on what puts the organization in this leadership position?
KV: Each of the organizations that represent hyperCORE are long standing industry leaders who have been vetted for their excellence in clinical research – efficient start up timelines, proficient enrollment with exceptional quality. Collectively, we are able to strategize together in a meaningful way that best supports our patients, research participants and industry partners.
This group embraces change management and is willing to support each other through that process. What better way to strive for excellence – together we are stronger as opposed to individuals reinventing the wheel.
OSP: What do you feel will be the most crucial areas of research for clinical research professionals to tackle in the near- and long-term future?
KV: In the near future, key issues surround forging ahead during a pandemic. How do we support both COVID treatment and vaccine trials while ensuring we continue to support non COVID work? How do we ensure our patients, staff and Pharma/CRO colleagues remain safe during this timeframe?
There remain areas of drug development that have difficulties in access to physicians, different ethnicities and specific patient populations so finding solutions to solve each of these problems will forever be challenges that we need to continue to pursue and overcome.
In the long-term term future, finding a solution that best supports all meaning regulators/pharma and CRO’s to allow for more flexibility in how the protocol is delivered in person vs. virtual and to allow approved technologies that may be adopted by a site/patient. Standardization is key to improve efficiencies so allowing the flexibility for more sophisticated sites to leverage this opportunity while at the same time support sites/patients access to these technologies that may not have this available to them; my ultimate goal will be the electronic medical record that is the electronic case report form.
It sure is an exciting time for the clinical research industry!